Trial Outcomes & Findings for Nursing Interventions Based on Protection Motivation Theory in Hypertensive Patients (NCT NCT05995977)

Results Overview

Scale, Walker et al. (1987) and revised again in 1996 (Walker and Hill-Polerecky 1996). The scale measures health-promoting behaviors associated with an individual's healthy lifestyle. The scale consists of 52 items in total and has 6 sub-factors. Subgroups are spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. The overall score of the scale gives the healthy lifestyle behaviors score. The lowest score for the whole scale is 52, and the highest score is 208. Higher values represent a better result. All items of the scale are positive. The rating is in the form of a 4-point likert. Never (1), sometimes (2), often (3), regularly (4). The Cronbach Alpha coefficient of the original scale is 0.94, and the Cronbach Alpha values of the sub-dimensions of the scale vary between 0.79 and 0.87.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).

Results posted on

2025-06-29

Participant Flow

First, 78 (sample number) participants who were not compliant with treatment (scoring "8 and above") were identified using the ASM antihypertensive drug treatment compliance scale. Participants were numbered from one to 78 and a list was created. Based on the order in the list, participants were assigned to the intervention and control groups via the web page (https://www.random.org/) using the simple randomization method. Group assignment was made by an expert to ensure blinding.

Participant milestones

Participant milestones
Measure	Intervention Group That Applied Nursing Interventions The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension
Overall Study STARTED	39	39
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group That Applied Nursing Interventions The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group That Applied Nursing Interventions n=39 Participants The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory n=39 Participants Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension	Total n=78 Participants Total of all reporting groups
Age, Continuous	51.54 years STANDARD_DEVIATION 5.15 • n=39 Participants	51.28 years STANDARD_DEVIATION 5.12 • n=39 Participants	51.41 years STANDARD_DEVIATION 5.11 • n=78 Participants
Sex: Female, Male Female	20 Participants n=39 Participants	18 Participants n=39 Participants	38 Participants n=78 Participants
Sex: Female, Male Male	19 Participants n=39 Participants	21 Participants n=39 Participants	40 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).

It was developed by Morisky, Green and Levine. There are a total of 9 statements in the scale that define drug-taking behavior. In the first 8 questions, answers are answered as Yes and No, and yes answers are coded as "1" and no answers as "0". In the ninth question, there are "1" never/rarely, "2" sometimes, "3" sometimes, "4" usually, "5" always and one option is marked. The Cronbach's alpha coefficient of the scale was reported as 0.82 in the whole scale. The total score of the scale varies between '1-13'. In the aforementioned study, the definitions of compatible and incompatible with antihypertensive drug treatment were determined according to the 80% cut-off point. Accordingly, individuals who scored "1-7" according to the total scale score were defined as compatible with the treatment, while participants who scored "8 and above" were defined as non-adherent to the treatment.

Outcome measures

Outcome measures
Measure	Intervention Group That Applied Nursing Interventions n=39 Participants The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory n=39 Participants Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension
Scale of Adherence to Antihypertensive Drug Treatment T0	9.31 score on a scale Standard Deviation 1.28	9.51 score on a scale Standard Deviation 1.21
Scale of Adherence to Antihypertensive Drug Treatment T1	7.86 score on a scale Standard Deviation 1.99	9.23 score on a scale Standard Deviation 0.84
Scale of Adherence to Antihypertensive Drug Treatment T2	8.14 score on a scale Standard Deviation 1.81	9.23 score on a scale Standard Deviation 0.84

PRIMARY outcome

Timeframe: Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).

Scale, Walker et al. (1987) and revised again in 1996 (Walker and Hill-Polerecky 1996). The scale measures health-promoting behaviors associated with an individual's healthy lifestyle. The scale consists of 52 items in total and has 6 sub-factors. Subgroups are spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. The overall score of the scale gives the healthy lifestyle behaviors score. The lowest score for the whole scale is 52, and the highest score is 208. Higher values represent a better result. All items of the scale are positive. The rating is in the form of a 4-point likert. Never (1), sometimes (2), often (3), regularly (4). The Cronbach Alpha coefficient of the original scale is 0.94, and the Cronbach Alpha values of the sub-dimensions of the scale vary between 0.79 and 0.87.

Outcome measures

Outcome measures
Measure	Intervention Group That Applied Nursing Interventions n=39 Participants The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory n=39 Participants Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension
Healthy Lifestyle Behaviors Scale T₀	119.90 score on a scale Standard Deviation 11.10	119.05 score on a scale Standard Deviation 16.20
Healthy Lifestyle Behaviors Scale T₁	132.11 score on a scale Standard Deviation 16.76	122.23 score on a scale Standard Deviation 12.96
Healthy Lifestyle Behaviors Scale T₂	131.53 score on a scale Standard Deviation 16.88	121.97 score on a scale Standard Deviation 13.08

SECONDARY outcome

Timeframe: Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).

Systolic blood pressure were measured by the researcher using a calibrated mercury-manual sphygmomanometer (sphygmomanometer-Erka Perfect Aneroid/Germany) and stethoscope. Step 1: The patient should rest quietly and comfortably for 5 minutes with his feet flat on the floor and remove the clothes from the arm to be measured. Step 2: Supporting the patient's arm at the level of the right atrium and placing the cuff on the bare arm. Step 3: Palpating the radial artery and inflating the cuff 20-30 mmHg after the loss of the pulse, then relaxing the cuff pressure to 2 mmHg per second and listening for the Korotkoff sounds. Step 4: Determining the first heard sound (Korotkoff 1) as systolic blood pressure, and the last Korotkoff sound as diastolic blood pressure. Step 5: Take two measurements 1-2 minutes apart and take the average of the two readings 6th step: Oral and written presentation of systolic blood pressure and diastolic blood pressure values to the patient

Outcome measures

Outcome measures
Measure	Intervention Group That Applied Nursing Interventions n=39 Participants The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory n=39 Participants Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension
Systolic Blood Pressure T₀	148.46 mm Hg Standard Deviation 6.50	147.82 mm Hg Standard Deviation 6.77
Systolic Blood Pressure T₁	140.56 mm Hg Standard Deviation 8.85	148.14 mm Hg Standard Deviation 5.95
Systolic Blood Pressure T₂	136.81 mm Hg Standard Deviation 11.54	148.86 mm Hg Standard Deviation 6.31

SECONDARY outcome

Timeframe: Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).

Diastolic blood pressure were measured by the researcher using a calibrated mercury-manual sphygmomanometer (sphygmomanometer-Erka Perfect Aneroid/Germany) and stethoscope. Step 1: The patient should rest quietly and comfortably for 5 minutes with his feet flat on the floor and remove the clothes from the arm to be measured. Step 2: Supporting the patient's arm at the level of the right atrium and placing the cuff on the bare arm. Step 3: Palpating the radial artery and inflating the cuff 20-30 mmHg after the loss of the pulse, then relaxing the cuff pressure to 2 mmHg per second and listening for the Korotkoff sounds. Step 4: Determining the first heard sound (Korotkoff 1) as systolic blood pressure, and the last Korotkoff sound as diastolic blood pressure. Step 5: Take two measurements 1-2 minutes apart and take the average of the two readings 6th step: Oral and written presentation of systolic blood pressure and diastolic blood pressure values to the patient

Outcome measures

Outcome measures
Measure	Intervention Group That Applied Nursing Interventions n=39 Participants The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes. Nursing interventions based on protection motivation theory in patients with hypertension: The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.	Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory n=39 Participants Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension
Diastolic Blood Pressure T₀	93.08 mm Hg Standard Deviation 3.56	92.05 mm Hg Standard Deviation 2.74
Diastolic Blood Pressure T₁	87.78 mm Hg Standard Deviation 4.54	90.57 mm Hg Standard Deviation 3.16
Diastolic Blood Pressure T₂	87.78 mm Hg Standard Deviation 5.79	90.43 mm Hg Standard Deviation 2.81

Adverse Events

Intervention Group That Applied Nursing Interventions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individuals Who do Not Apply Nursing Interventions Based on Protection Motivation Theory

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Handan Altunkan

Karaman Provincial Health Directorate

Phone: 05367443152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place